The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4101–4125 of 7439

  • CriticalFDA (Devices)·Z-1275-2016·2016-04-13

    FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

    Product
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1020-2016·2016-04-13

    Country Life Raw Shelled Pistachios Recalled for Salmonella Risk

    Country Life Natural Foods is recalling raw shelled pistachios due to potential Salmonella contamination.

    Product
    Country Life Natural Foods Labeled SHELLED PISTACHIOS RAW NET WT. 2lb (906 g) plastic bags item 030244 and Batch 1357 batch number 1357 in the lower left corner of the label
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0904-2016·2016-04-13

    Peking Food LLC Recalls Chef Hon Steamed Buns for Undeclared Eggs

    Peking Food LLC is recalling Chef Hon brand steamed buns with seafood because they contain undeclared eggs. The product was distributed across 22 states and Puerto Rico.

    Product
    Chef Hon brand STEAMED BUNS WITH SEAFOOD MARINATED IN XO-SAUCE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00163 0, KEEP FROZEN --- Peking Food LLC Brooklyn, NY
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-1028-2016·2016-04-13

    GSN Organic Mediterranean Blend Recalled for Salmonella Contamination

    R.J. Van Drunen & Sons is recalling GSN organic Mediterranean Blend because an FDA sample tested positive for Salmonella.

    Product
    GSN organic Mediterranean Blend packaged in 44 lb. polyethylene liner inside of a cardboard box.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1019-2016·2016-04-13

    Wholesome Soy Mung Bean Sprouts Recalled for Listeria Contamination

    Wholesome Soy Products is recalling mung bean sprouts in Illinois due to Listeria monocytogenes contamination found by FDA environmental sampling.

    Product
    Mung bean sprouts are packaged 1 lb., 5 lbs., 10 lbs., 15 lbs., or 30 lbs. per plastic bag.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1004-2016·2016-04-06

    Heritage International Recalls Trader Joe's Raw Cashew Pieces for Salmonella

    Heritage International is recalling Trader Joe's Raw Cashew Pieces due to potential Salmonella contamination. The product was distributed to specific U.S. Trader Joe's locations.

    Product
    Trader Joe's Nuts Raw Cashew Pieces NET Wt. 18 oz (1 LB) UPC Code: 0050 5154 Product of Thailand, Vietnam, & India Packaged in Thailand
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0902-2016·2016-04-06

    Lipari Foods Recalls Fancy Fruit & Nut Mix Due to Salmonella Risk

    Lipari Foods, Inc. is recalling Fancy Fruit & Nut Mix products because they may be contaminated with Salmonella.

    Product
    Fancy Fruit & Nut Mix 9-oz. retail plastic tub or 25-lb. bulk plastic bag. 12, 9-oz. tubs per case. 1, 25-lb. bag per case.
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-0782-2016·2016-03-30

    Southeastern Grocers Recalls Bi-Lo Fruit Trays for Listeria

    Southeastern Grocers is recalling Bi-Lo fruit trays containing cantaloupe, grapes, and strawberries because a sample tested positive for Listeria species.

    Product
    Bi-Lo, Walters Fruit Tray Cantaloupe (Cantaloupe, Grapes and Strawberries), various net wt., in clear plastic trays.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0780-2016·2016-03-30

    Southeastern Grocers Recalls Bi-Lo Mixed Melon Chunks Due to Listeria

    Southeastern Grocers is recalling Bi-Lo Mixed Melon Chunks in Georgia because a product sample tested positive for Listeria species.

    Product
    Bi-Lo, Mixed Melon Chunks (in Medium, and Large containers), containing Cantaloupe, Honeydew and Watermelon, various net wt. in clear plastic containers.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0766-2016·2016-03-23

    Wilderness Family Naturals Tomato Basil Soup Recalled for Milk Contamination

    Wilderness Family Naturals is recalling specific Tomato Basil Soup products due to potential milk contamination. The recall covers over 5,500 units distributed in the US and Canada.

    Product
    Morning Star Disaster Supplies Tomato Basil Soup, Net Wt 3.88 oz (110 g), UPC 853328-006120, Foil Bag Wilderness Family Naturals Quick Meal Tomato Basil Soup, Net Wt 3.88 oz (110 g). UPC 853328-006243, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0772-2016·2016-03-23

    Wilderness Family Naturals Recalls Butternut Squash Soup for Milk Contamination

    Wilderness Family Naturals is recalling specific lots of Butternut Squash Soup due to potential milk contamination from an ingredient.

    Product
    Morning Star Disaster Supplies Butternut Squash Soup, Net Wt 4.75oz (135 g). UPC 853328-006113, Foil Bag Wilderness Family Naturals Quick Meal Butternut Squash Soup, Net Wt 4.75 oz (135 g). UPC 853328-006182, Foil Bag
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0740-2016·2016-03-16

    R&D Technical Center Recalls Peanut Drop Coating for Listeria

    R&D Technical Center is recalling Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop after a positive Listeria monocytogenes test.

    Product
    Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG)
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1063-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0734-2016·2016-03-16

    Living Tree Community Foods Recalls Organic Macadamia Butter for Salmonella Risk

    Living Tree Community Foods is recalling Organic Macadamia Butter due to potential Salmonella contamination. Consumers should stop using the product.

    Product
    Living Tree Community Foods Organic Macadamia Butter, 8 oz. glass jar. Certified Organic. UPC 64143200987
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0344-2016·2016-03-16

    Homestat Farm Organic Oats Recalled for Salmonella Typhimurium Contamination

    Homestat Farm is recalling Organic Quick Steel Cut Oats & Chia with Flax and Rye Flakes because the flax meal ingredient tested positive for Salmonella Typhimurium.

    Product
    ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0730-2016·2016-03-16

    Picnic Gourmet Herbed Goat Cheese Spread Recalled for Listeria

    Picnic Gourmet Spreads LLC is recalling Herbed Goat Cheese Spread after a related product tested positive for Listeria monocytogenes.

    Product
    Picnic Gourmet Spreads ( Herbed Goat Cheese Spread) 8 oz containers .12 Containers per case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0772-2016·2016-03-16

    Rhino 7 Platinum 3000 Recalled for Undeclared Active Ingredients

    Tf Supplements is recalling Rhino 7 Platinum 3000 because it contains undeclared desmethyl carbondenafil and dapoxetine and was marketed without an approved NDA or ANDA.

    Product
    Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0725-2016·2016-03-16

    Illes Food Ingredients Recalls Asiago Cheese Sauce Seasoning for Salmonella

    Illes Food Ingredients Ltd. is recalling 50 bags of Asiago Cheese Sauce Seasoning because the product tested positive for Salmonella.

    Product
    Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0733-2016·2016-03-16

    Living Tree Community Foods Recalls Organic Macadamia Nuts Due to Salmonella Risk

    Living Tree Community Foods is recalling 4 oz. pouches of Organic Macadamia Nuts due to potential Salmonella contamination. The recall affects 195 units distributed in 23 US states.

    Product
    Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch. Certified Organic
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Drugs)·D-0771-2016·2016-03-16

    Tf Supplements Recalls Rhino 7 3000 Due to Undeclared Ingredients

    Tf Supplements is recalling Rhino 7 3000 bottles because they contain undeclared desmethyl carbondenafil and dapoxetine and were marketed without an approved NDA or ANDA.

    Product
    RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0637-2016·2016-03-09

    Braga Organic Farms Recalls Organic Trail Mix Due to Salmonella

    Braga Organic Farms is recalling Organic Trail Mix because an ingredient tested positive for Salmonella. The product was sold in multiple states and online.

    Product
    Braga Organic Farms Organic Trail Mix, Raw; Certified Organic, USDA Organic. GMO Free, Peanut Free, Gluten Free Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags. Ingredients: Organic Pistachios, organic almonds, Organic walnuts, Organic Jumbo Flam
    Category
    Food
    Distribution
    45 states